Manufacturing Engineer

Role: Manufacturing Engineer

Location: North Carolina, United States

We are seeking a Manufacturing Engineer to support production operations within a regulated pharmaceutical or medical device manufacturing environment. This role will focus on process optimization, equipment support, validation activities, and continuous improvement initiatives while ensuring compliance with cGMP, FDA, and ISO standards. The ideal candidate has hands-on experience in regulated manufacturing and thrives in cross-functional settings.

Key Responsibilities

• Support day-to-day manufacturing operations to ensure safe, efficient, and compliant production
• Develop, improve, and optimize manufacturing processes for drug products and/or medical devices
• Author and revise manufacturing documentation including SOPs, batch records, work instructions, and protocols
• Lead or support process validation, equipment qualification (IQ/OQ/PQ), and technology transfers
• Perform root cause investigations and implement CAPAs for manufacturing deviations and nonconformances
• Collaborate with Quality, Validation, Maintenance, Supply Chain, and R&D teams
• Drive Lean Manufacturing, Six Sigma, and continuous improvement initiatives
• Support new equipment installation, commissioning, and automation projects
• Ensure compliance with cGMP, FDA 21 CFR Parts 210/211, ISO 13485, and ISO 14971
• Support audits and inspections (FDA, ISO, internal)

Required Qualifications

• Bachelor’s degree in Manufacturing, Mechanical, Chemical, Biomedical, or Industrial Engineering
• 2–7+ years of manufacturing engineering experience in pharma, biotech, or medical device industries
• Strong knowledge of cGMP and regulated manufacturing environments
• Experience with process validation, equipment qualification, and change control
• Familiarity with deviation investigations and CAPA processes
• Excellent technical documentation and communication skills
• Ability to work onsite in a fast-paced production environment